NL-OMON52660招募中不适用
Clinical trial to evaluate safety and efficacy of the C2 CryoBalloon 180° Ablation System for the treatment of dysplastic Barrett*s esophagus: CBAS180 de-escalation study - CBAS180 de-escalation study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •1) Flat type BE esophagus, with an indication for ablation therapy, defined as:
- •a) Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
- •b) Residual BE with any grade of dysplasia after endoscopic resection (by means
- •of EMR or ESD) to treat non-flat BE, >=6 weeks prior to enrolling the patient to
- •this study. The ER pathology should indicate endoscopic treatment (i.e. only
- •mucosal invasion or limited submucosal invasion (sm1), no lymphovascular
- •infiltration, free vertical resection margins and not poorly differentiated).
- •2) Prague Classification Score of C<=3 and M>=1.
- •3) Patients should be ablation-naïve, meaning they have not undergone any
- •previous endoscopic ablation therapy of the esophagus.
- •4) Older than 18 years of age at time of consent.
- •5) Fit for endoscopic therapy per institution*s standards.
- •6) Provides written informed consent on the IRB-approved informed consent form.
- •7) Willing and able to comply with follow-up requirements.
排除标准
- •1) Esophageal stenosis preventing advancement of a therapeutic endoscope.
- •2) Any endoscopically visualized lesion such as ulcers, masses or nodules.
- •Neoplastic nodules must first be treated with ER >=6 weeks prior to planned
- •treatment under this protocol.
- •3) Prior ER of >2cm in length and/or >50% of the esophageal lumen
- •circumference.
- •4) History of locally advanced (>sm1) esophageal cancer.
- •5) History of esophageal varices.
- •6) Prior distal esophagectomy.
- •7) Active esophagitis LA grade B or higher.
- •8) Severe medical comorbidities precluding endoscopy.
- •9) Uncontrolled coagulopathy.
- •10) Pregnant or planning to become pregnant during period of study.
研究者
相似试验
招募中
3 期
Clinical trial to evaluate safety and efficacy of radiofrequency ablation for malignant tumors located outside the livermalignant tumors which have lesions located outside the liverJPRN-UMIN000012109Division of Diagnostic Imaging and Minimally Invasive Therapy, Juntendo University Graduate School of Medicine20
已完成
不适用
Clinical trial to evaluate efficacy and safety of low molecular collagen peptides for joint paiKCT0007584Yonsei University Health System, Severance Hospital78
已完成
3 期
Clinical trial to evaluate efficacy and safety of KCS03 stent in a native coronary lesioStable angina, unstable angina and non-ST elevated myocardial infarction with de novo or restenotic coronary lesionsJPRN-UMIN000010422Kaneka Corporation115
已完成
2 期
Clinical trial to evaluate efficacy and safety of cyclophosphamide, bortezomib and dexamethasone (CBD) induction and autologous stem cell transplantation for patients for newly diagnosed multiple myeloma (NBMT-ASCT1201)multiple myelomaJPRN-UMIN000008399Toyohashi Municipal Hospital Division of Hematology and Oncology54
已完成
3 期
Clinical trial to evaluate efficacy and safety of apheresis therapy on peripheral arterial disease with critical limb ischemia.Peripheral arterial diseaseJPRN-UMIN000020336Kaneka Corporation61
